ID

19882

Beschrijving

The purpose of this study is to determine the safety and efficacy of natalizumab in the treatment of individuals who have been diagnosed with relapsing remitting multiple sclerosis (MS). It is hoped that natalizumab will prevent certain types of white blood cells from moving out of the bloodstream into organs, including the brain, that are being damaged by autoimmune disease (a disease in which the body's own immune system attacks certain organs). These white blood cells are thought to cause inflammation that can result in lesions (small areas of damage) in the brain. These lesions are thought to be the cause of relapses and disability in MS. Documentation process: This form is to be obtained in Screening #1, Screening #2, Screening #3, Baseline week 0, week 12, week 24, week 36, week 48, week 60, week 72, week 84, week 96, week 108, week 120, week 128 and Premature Study Withdrawl.

Trefwoorden

Versies (2)
  1. 23-01-17 23-01-17 -
  2. 30-01-17 30-01-17 -
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30 januari 2017

DOI

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Creative Commons BY-NC 3.0
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Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

Engels

Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulieren  
Nine Hole Peg Test Dominant Hand Trial One
Beschrijving

Nine Hole Peg Test Dominant Hand Trial One

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
Time
Beschrijving

Time

Datatype

float

Maateenheden
  • seconds
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance
Beschrijving

Circumstances

Datatype

text

Alias
UMLS CUI [1,1]
C1821459
UMLS CUI [1,2]
C0451335
UMLS CUI [1,3]
C0449722
If trial was not completed:
Beschrijving

Not completed

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
Specify reason if a, b or c is marked:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1]
C0392360
Nine Hole Peg Test Dominant Hand Trial Two
Beschrijving

Nine Hole Peg Test Dominant Hand Trial Two

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
Time
Beschrijving

Time

Datatype

float

Maateenheden
  • seconds
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Beschrijving

Circumstances

Datatype

text

Alias
UMLS CUI [1,1]
C1821459
UMLS CUI [1,2]
C0451335
UMLS CUI [1,3]
C0449722
If trial was not completed:
Beschrijving

not completed

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0449722
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
Specify reason if a, b or c is marked:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1]
C0392360
If two trials were completed, did it take more than two attempts to get the two successful trials?
Beschrijving

Number of attempts

Datatype

boolean

Alias
UMLS CUI [1]
C3163850
If "Yes", specify reason(s) for more than two attempted trials:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C3163850
Nine Hole Peg Test Non-dominant Hand Trial One
Beschrijving

Nine Hole Peg Test Non-dominant Hand Trial One

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0445549
Time
Beschrijving

Time

Datatype

float

Maateenheden
  • seconds
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Beschrijving

Circumstances

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C1821459
If trial was not completed:
Beschrijving

Not completed

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
Specify reason if a, b or c is marked
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1]
C0392360
Nine Hole Peg Test Non-dominant Hand Trial Two
Beschrijving

Nine Hole Peg Test Non-dominant Hand Trial Two

Alias
UMLS CUI-1
C0451335
UMLS CUI-2
C0449722
Time
Beschrijving

Time

Datatype

float

Maateenheden
  • seconds
Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C0040223
seconds
For a completed trial, record any circumstances that affected the patient's performance:
Beschrijving

Circumstances

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C1821459
If trial was not completed:
Beschrijving

Not completed

Datatype

text

Alias
UMLS CUI [1,1]
C0451335
UMLS CUI [1,2]
C0445549
UMLS CUI [1,3]
C0750480
UMLS CUI [1,4]
C2732579
Specify reason ist a, b or c is marked:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1]
C0392360
If two trials were completed, did it take more than two attempts to get the two successful trials?
Beschrijving

Number of attempts

Datatype

boolean

Alias
UMLS CUI [1]
C3163850
If "Yes", specify reason(s) for more than two attempted trials:
Beschrijving

Reason

Datatype

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C3163850
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Similar models

Nine Hole Peg Test CRFs Multiple Sclerosis Tysabri NCT00027300

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Nine Hole Peg Test Dominant Hand Trial One
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
Time
Item
Time
float
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance
text
C1821459 (UMLS CUI [1,1])
C0451335 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,3])
Item
If trial was not completed:
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Reason
Item
Specify reason if a, b or c is marked:
text
C0392360 (UMLS CUI [1])
Item Group
Nine Hole Peg Test Dominant Hand Trial Two
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
Time
Item
Time
float
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance:
text
C1821459 (UMLS CUI [1,1])
C0451335 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,3])
Item
If trial was not completed:
text
C0451335 (UMLS CUI [1,1])
C0449722 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Reason
Item
Specify reason if a, b or c is marked:
text
C0392360 (UMLS CUI [1])
Number of attempts
Item
If two trials were completed, did it take more than two attempts to get the two successful trials?
boolean
C3163850 (UMLS CUI [1])
Reason
Item
If "Yes", specify reason(s) for more than two attempted trials:
text
C0392360 (UMLS CUI [1,1])
C3163850 (UMLS CUI [1,2])
Item Group
Nine Hole Peg Test Non-dominant Hand Trial One
C0451335 (UMLS CUI-1)
C0445549 (UMLS CUI-2)
Time
Item
Time
float
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance:
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C1821459 (UMLS CUI [1,3])
Item
If trial was not completed:
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Reason
Item
Specify reason if a, b or c is marked
text
C0392360 (UMLS CUI [1])
Item Group
Nine Hole Peg Test Non-dominant Hand Trial Two
C0451335 (UMLS CUI-1)
C0449722 (UMLS CUI-2)
Time
Item
Time
float
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Circumstances
Item
For a completed trial, record any circumstances that affected the patient's performance:
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C1821459 (UMLS CUI [1,3])
Item
If trial was not completed:
text
C0451335 (UMLS CUI [1,1])
C0445549 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C2732579 (UMLS CUI [1,4])
completed
Code List
If trial was not completed:
CL Item
unable to complete trial due to MS-related physical limitation (a)
CL Item
unable to complete trial due to other physical limitations (b)
CL Item
other (c)
Reason
Item
Specify reason ist a, b or c is marked:
text
C0392360 (UMLS CUI [1])
Number of attempts
Item
If two trials were completed, did it take more than two attempts to get the two successful trials?
boolean
C3163850 (UMLS CUI [1])
Reason
Item
If "Yes", specify reason(s) for more than two attempted trials:
text
C0392360 (UMLS CUI [1,1])
C3163850 (UMLS CUI [1,2])
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